ANZCTR - Registration

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12618001035213

Ethics application status

Approved

Date submitted

14/06/2018

Date registered

20/06/2018

Date last updated

10/01/2019

Date data sharing statement initially provided

10/01/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

A pilot trial of the MAnagement of Systolic blood pressure during Thombectomy by
Endovascular Route for acute ischaemic STROKE (MASTERSTROKE)

Scientific title

A pragmatic, prospective, multi-centre, double-blind randomised controlled pilot trial of the MAnagement of Systolic blood pressure during Thrombectomy by Endovascular Route for acute ischaemic STROKE (MASTERSTROKE)

Secondary ID [1]

ADHB 7773

Universal Trial Number (UTN)

Trial acronym

MASTERSTROKE

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Stroke

Thrombectomy

Condition category

Condition code

Stroke

Ischaemic

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Augmented - maintain SBP at 170mmHg +/-10mmHg from the onset of anaesthesia until recanalization. Maintenance of blood pressure is done at the discretion of the treating anaesthetist; according to New Zealand Society of Anaesthetists 2016 Guidelines

Intervention code [1]

Treatment: Other

Comparator / control treatment

Standard’ – maintain SBP at 140mmHg +/-10mmHg from the onset of anaesthesia until recanalization utlising all normal anaesthesia blood pressure management.

Control group

Active

Outcomes

Primary outcome [1]

Functional Recovery as determined by a modified Rankin Score scores of 0, 1 or 2 at 3 months.

Timepoint [1]

Day 90 Post thrombectomy

Secondary outcome [1]

Neurological improvement defined by National Institute of Health Stroke Scale (NIHSS)

Timepoint [1]

24 hours post thrombectomy

Secondary outcome [2]

all-cause mortality confirmed by patient follow-up and clinical note review.

Timepoint [2]

90 days post thrombectomy

Secondary outcome [3]

Proportion of patients with intra-procedural complications (vessel perforation, dissection, devicerelated complications, haemodynamic and airway complications, reperfusion syndrome, thrombus migration or restenosis, seizures during treatment, groin haematoma)

Timepoint [3]

From randomization until day 90

Secondary outcome [4]

Proportion of patients with symptomatic intracranial haemorrhage (within 36 hours of treatment, associated with an increase of NIHSS of at least 4 points from baseline), including : subarachnoid haemorrhage associated with clinical symptoms symptomatic intracerebral haemorrhage (parenchymal haematoma type 2).

Timepoint [4]

From randomisation until 36 hours post treatment.

Eligibility

Key inclusion criteria

Functionally independent patients (mRS 0 – 2) diagnosed with anterior circulation stroke (internal carotid artery or proximal M1 or M2 segment of middle cerebral artery)
presenting within six hours of stroke onset who fulfil current guidelines for thrombectomy.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Rescue’ procedures eg acute ischaemic stroke associated with major medical procedures such as coronary artery stenting and coronary artery bypass.
• Prestroke
mRS score of 3 (indicating previous disability)
• Contraindication to imaging with contrast agents
• Any terminal illness with expected survival less than 1 year
• Pregnant women
• Any medical condition where there is a contraindication to either treatment arm, or haemodynamic targeting will be problematic eg. severe aortic regurgitation

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

sealed opaque envelopes

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation using a randomisation table created by computer software

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Statistical Methods
Sample size is 30 if the trial remains a single-centre pilot and 50 if Wellington and Christchurch Hospitals participate. This is consistent with previous pilot trial experience and published guidelines and is estimated to be the number recruited over a four-month period if 50% of eligible patients are recruited. Primary analyses will be by intention to treat (ITT). Feasibility outcomes will be described with simple descriptive statistics. Inferential statistics for the primary and secondary outcomes will be with chi-squared testing. Any continuous data will be transformed as appropriate, before Students t-testing. P-values will be reported when appropriate. The primary and secondary outcomes will report the event rate and 95% confidence interval (CI).

Sample size for a large trial will be based on the proportion of patients experiencing good late neurological outcomes (mRS 0-2 at 3 months). Expected sample sizes based on initial proportions of good outcome of 54% (current ADHB value), 62%, and 71% (EXTEND-IA values, a trial with selection criteria favouring better overall outcome than current clinical inclusion criteria), and absolute treatment effects of 10%, 8% and 5%. For context, the absolute treatment effect in recategorization to good outcome was 20% in the pooled trial meta-analysis.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

21/06/2018

Actual

24/06/2018

Date of last participant enrolment

Anticipated

30/06/2019

Actual

5/10/2018

Date of last data collection

Anticipated

1/10/2019

Actual

9/01/2019

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Auckland

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Auckland District Health Board Charitable Trust

Address [1]

Auckland District Health Board Research Office Level 14, Support Building Auckland City Hospital Park Rd Grafton Auckland 1023

Country [1]

New Zealand

Funding source category [2]

Other Collaborative groups

Name [2]

ANZCA Clinical Trials Network Executive

Address [2]

ANZCA House 630 St Kilda Road Melbourne Victoria 3004

Country [2]

Australia

Primary sponsor type

Individual

Name

Dr Douglas Campbell

Address

Department of Anaesthesia
Perioperative Services
Level 8, Support Building
Auckland City Hospital
Park Road
Grafton
Auckland 1023

Country

New Zealand

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern B Health and Disability Ethics Committee

Ethics committee address [1]

Health and Disability Ethics Committees
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

21/03/2018

Approval date [1]

29/05/2018

Ethics approval number [1]

18/NTB/55

Summary

Brief summary

Internationally stroke ranks fifth among all causes of death and is considered the second leading healthcare burden. Over the last 5 years endovascular thrombectomy (clot retrieval) has been effective for the treatment of acute large vessel ischaemic stroke, with significant reductions in long term patient disability compared to standard
treatment. However, there is minimal definitive guidance on the importance of haemodynamic management during the procedure, which may be linked to poor functional recovery. The brain is especially vulnerable to BP variation during the acute stroke period due to ischaemia from the clot, reperfusion injury and impaired cerebral autoregulation. Theoretically, arterial hypertension may be detrimental as it leads to encephalopathy, cerebral oedema and haemorrhagic transformation of ischaemic tissue. Conversely, arterial hypotension may lead to hypoperfusion of the ischaemic brain and other organs. Current evidence is limited to large observational studies. Auckland DHB is one of 3 DHBs around New Zealand to provide a 24 hour thrombectomy service. This pilot study will examine the effect of two systolic blood pressures (SBP) management arms during clot retrieval on outcomes in patients with acute ischaemic stroke.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Carolyn Deng

Address

Department of Anaesthesia Perioperative Services Level 8, Support Building Auckland City Hospital Park Road Grafton Auckland 1023

Country

New Zealand

Phone

+6493757095

Fax

+6493754578

[email protected]

Contact person for public queries

Name

Davina Mcallister

Address

Department of Anaesthesia Perioperative Services Level 8, Support Building Auckland City Hospital Park Road Grafton Auckland 1023

Country

New Zealand

Phone

+6493757095

Fax

+6493754378

[email protected]

Contact person for scientific queries

Name

Doug Campbell

Address

Department of Anaesthesia Perioperative Services Level 8, Support Building Auckland City Hospital Park Road Grafton Auckland 1023

Country

New Zealand

Phone

+6493757095

Fax

+6493754378

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

No
No IPD sharing reason/comment: no decision has been reached by the steering committee around what data may potentially available in the public domain.

What supporting documents are/will be available?

Doc. No.	Type	Other Details	Attachment
1013	Informed consent form	Best interest statement by independent physician	Study-related document.pdf
1014	Study protocol		Study-related document.pdf
1015	Informed consent form	Information for Families and Friends of patients e... [More Details]	Study-related document.pdf
1016	Informed consent form	Provision for follow-up of patients involved in MA... [More Details]	Study-related document.pdf
1017	Ethical approval		Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	A pilot randomised controlled trial of the management of systolic blood pressure during endovascular thrombectomy for acute ischaemic stroke.	2020	https://dx.doi.org/10.1111/anae.14940

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically